Report from SACHRP, Part 2: The Calcified Common Rule

Part of the SACHRP discussion last week concerned a provision of the Common Rule to which I had not paid much attention. As the Subpart A subcommittee noted, 45 CFR 46.117(c)(1) provides that

An IRB may waive the requirement for the investigator to obtain a signed consent form for some or all subjects if it finds . . . that the only record linking the subject and the research would be the consent document and the principal risk would be potential harm resulting from a breach of confidentiality. Each subject will be asked whether the subject wants documentation linking the subject with the research, and the subject's wishes will govern . . .

Several committee members noted that this last bit--about asking the subject if she wants the documentation that an IRB has determined will put her at risk--is pretty stupid. David Forster noted that offering a signed document can create unnecessary distrust. Neil Powe and Daniel Nelson suggested that it would be a significant burden for a researcher to devise and gain approval for a consent form on the off chance that a subject will demand one. Everyone seemed to agree that this provision is never enforced, and that it would be a bad idea if it were.

But what to do about it? As members of an official body, the committee members were clearly uncomfortable recommending that IRBs ignore a provision of the Common Rule. Yet they all seemed to think that amending the Common Rule was impossible.

This kind of defeatism distresses me. Since the Common Rule was promulgated in 1991, we've amended the Constitution, added an executive department to the cabinet, and brought professional baseball back to Washington, D.C. I'm sure it's a pain in the neck to bring together all the Common Rule signatories, but can't it be done every seven years, or ten? Or are we to endure these kinds of errors for a century?

I have not yet figured out who put in the provision that subjects be offered documentation even when it threatens them. The National Commission recommended no such requirement, yet it appeared in the draft regulations of August 1979. Someone in the Department of Health, Education, and Welfare made a mistake thirty years ago, and now we're stuck with it.